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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04494425




Registration number
NCT04494425
Ethics application status
Date submitted
20/07/2020
Date registered
31/07/2020

Titles & IDs
Public title
Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer
Scientific title
A Phase 3, Randomized, Multi-center, Open-label Study of Trastuzumab Deruxtecan (T-DXd) Versus Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Breast Cancer Patients Whose Disease Has Progressed on Endocrine Therapy in the Metastatic Setting (DESTINY-Breast06)
Secondary ID [1] 0 0
2019-004493-26
Secondary ID [2] 0 0
D9670C00001
Universal Trial Number (UTN)
Trial acronym
DB-06
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced or Metastatic Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Trastuzumab deruxtecan
Treatment: Drugs - Capecitabine
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Nab-Paclitaxel

Experimental: Trastuzumab deruxtecan - Trastuzumab deruxtecan (T-DXd; DS-8201a) arm

Active comparator: Standard of Care - Investigator's choice standard of care chemotherapy (capecitabine, paclitaxel, nab-paclitaxel) arm


Treatment: Drugs: Trastuzumab deruxtecan
Trastuzumab deruxtecan by intravenous infusion

Treatment: Drugs: Capecitabine
Investigator's choice standard of care single agent chemotherapy; capecitabine tablets will be given orally.

Treatment: Drugs: Paclitaxel
Investigator's choice standard of care single agent chemotherapy; paclitaxel by intravenous infusion.

Treatment: Drugs: Nab-Paclitaxel
Investigator's choice standard of care single agent chemotherapy; nab-paclitaxel by intravenous infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) - in HR+, HER2-low populaton
Timepoint [1] 0 0
Until progression or death, assessed up to approximately 60 months
Secondary outcome [1] 0 0
Overall Survival (OS) - in HR+, HER2-low population
Timepoint [1] 0 0
Until death, assessed up to approximately 60 months
Secondary outcome [2] 0 0
Progression Free Survival (PFS) - in intent to treat (ITT) population (HER2-Low and HER2 IHC >0<1+)
Timepoint [2] 0 0
Until progression or death, assessed up to approximately 60 months
Secondary outcome [3] 0 0
Overall Survival - in intent to treat (ITT) population (HER2-Low and HER2 IHC >0<1+)
Timepoint [3] 0 0
Until death, assessed up to approximately 60 months
Secondary outcome [4] 0 0
Objective Response Rate (ORR) in HR+, HER-2 low populaton
Timepoint [4] 0 0
Until progression, assessed up to approximately 60 months
Secondary outcome [5] 0 0
Duration of response (DoR) - in HR+, HER-2 low populaton
Timepoint [5] 0 0
Until progression, assessed up to approximately 60 months
Secondary outcome [6] 0 0
Progression Free Survival by Investigator assessment - in the HR+, HER2-low population
Timepoint [6] 0 0
Until progression or death, assessed up to approximately 60 months
Secondary outcome [7] 0 0
Objective Response Rate (ORR) in the ITT population
Timepoint [7] 0 0
Until progression, assessed up to approximately 60 months
Secondary outcome [8] 0 0
Duration of response (DoR) - in the ITT population
Timepoint [8] 0 0
Until progression, assessed up to approximately 60 months
Secondary outcome [9] 0 0
PFS2 by Investigator assessment, time to first subsequent therapy (TFST) and time to second subsequent treatment or death (TSST) - in HR+, HER2-low and the ITT population
Timepoint [9] 0 0
Assessed up to approximately 60 months
Secondary outcome [10] 0 0
Safety and tolerability of drugs; number of adverse events (AEs)
Timepoint [10] 0 0
Up to follow-up period, approximately 60 months
Secondary outcome [11] 0 0
Serum concentration of trastuzumab deruxtecan
Timepoint [11] 0 0
Up to Cycle 8, approximately Week 24; each cycle is 21 days
Secondary outcome [12] 0 0
Immunogenicity of trastuzumab deruxtecan
Timepoint [12] 0 0
Up to follow-up period, approximately 60 months
Secondary outcome [13] 0 0
Health-related quality of life - EORTC-QLQ-C30
Timepoint [13] 0 0
Assessed up to approximately 60 months
Secondary outcome [14] 0 0
Time to deterioration in EORTC-QLQ-C30 scores
Timepoint [14] 0 0
Assessed up to approximately 60 months
Secondary outcome [15] 0 0
Health-related quality of life - EORTC QLQ-BR45
Timepoint [15] 0 0
Assessed up to approximately 60 months

Eligibility
Key inclusion criteria
Key

* Patients must be =18 years of age
* Pathologically documented breast cancer that:

1. is advanced or metastatic
2. has a history of HER2-low or negative expression by local test, defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) or HER2 IHC 0 (ISH- or untested)
3. has HER2-low or HER2 IHC >0 <1+ expression as determined by the central laboratory result established on a tissue sample taken in the metastatic setting
4. was never previously HER2-positive
5. is documented HR+ disease in the metastatic setting.
* No prior chemotherapy for advanced or metastatic breast cancer.
* Has adequate tumor samples for assessment of HER2 status
* Must have either:

1. disease progression within 6 months of starting first line metastatic treatment with an endocrine therapy combined with a CDK4/6 inhibitor or
2. disease progression on at least 2 previous lines of endocrine therapy with or without a targeted therapy in the metastatic setting. Of note with regards to the =2 lines of previous ET requirement: disease recurrence while on the first 24 months of starting adjuvant ET, will be considered a line of therapy; these patients will only require 1 line of ET in the metastatic setting.
* Has protocol-defined adequate organ and bone marrow function

Key
Minimum age
18 Years
Maximum age
105 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Ineligible for all options in the investigator's choice chemotherapy arm
* Lung-specific intercurrent clinically significant illnesses
* Uncontrolled or significant cardiovascular disease or infection
* Prior documented interstitial lung disease (ILD)/ pneumonitis that required steroids, current ILD/ pneumonitis, or suspected ILD/ pneumonitis that cannot be ruled out by imaging at screening.
* Patients with spinal cord compression or clinically active central nervous system metastases
* Prior randomization or treatment in a previous trastuzumab deruxtecan study regardless of treatment arm assignment
* Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study during the follow up period of a prior interventional study (prescreening for this study while a patient is on treatment in another clinical study is acceptable)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/07/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
19/06/2026
Actual
Sample size
Target
Accrual to date
Final
866
Recruitment in Australia
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Research Site - Adelaide
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Research Site - Birtinya
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Research Site - Darlinghurst
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Research Site - Murdoch
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Research Site - South Brisbane
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Research Site - St Leonards
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Research Site - Waratah
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5000 - Adelaide
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4575 - Birtinya
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2010 - Darlinghurst
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6150 - Murdoch
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4101 - South Brisbane
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2065 - St Leonards
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2298 - Waratah
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Gyor
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Chuo-ku
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State/province [200] 0 0
Saint-Petersburg
Country [201] 0 0
Russian Federation
State/province [201] 0 0
Sankt-Peterburg
Country [202] 0 0
Russian Federation
State/province [202] 0 0
Yaroslavl
Country [203] 0 0
Saudi Arabia
State/province [203] 0 0
Ar Riya?
Country [204] 0 0
Saudi Arabia
State/province [204] 0 0
Dammam
Country [205] 0 0
Saudi Arabia
State/province [205] 0 0
Jeddah
Country [206] 0 0
Saudi Arabia
State/province [206] 0 0
Riyadh
Country [207] 0 0
Singapore
State/province [207] 0 0
Bukit Merah
Country [208] 0 0
Singapore
State/province [208] 0 0
Singapore
Country [209] 0 0
Spain
State/province [209] 0 0
Barcelona
Country [210] 0 0
Spain
State/province [210] 0 0
Cordoba
Country [211] 0 0
Spain
State/province [211] 0 0
El Palmar
Country [212] 0 0
Spain
State/province [212] 0 0
La Coruña
Country [213] 0 0
Spain
State/province [213] 0 0
Madrid
Country [214] 0 0
Spain
State/province [214] 0 0
San Sebastián
Country [215] 0 0
Spain
State/province [215] 0 0
Sevilla
Country [216] 0 0
Spain
State/province [216] 0 0
Valencia
Country [217] 0 0
Sweden
State/province [217] 0 0
Göteborg
Country [218] 0 0
Sweden
State/province [218] 0 0
Stockholm
Country [219] 0 0
Sweden
State/province [219] 0 0
Uppsala
Country [220] 0 0
Sweden
State/province [220] 0 0
Växjö
Country [221] 0 0
Sweden
State/province [221] 0 0
Örebro
Country [222] 0 0
Taiwan
State/province [222] 0 0
Taichung
Country [223] 0 0
Taiwan
State/province [223] 0 0
Tainan
Country [224] 0 0
Taiwan
State/province [224] 0 0
Taipei
Country [225] 0 0
Taiwan
State/province [225] 0 0
Tao-Yuan
Country [226] 0 0
United Kingdom
State/province [226] 0 0
Cambridge
Country [227] 0 0
United Kingdom
State/province [227] 0 0
Cardiff
Country [228] 0 0
United Kingdom
State/province [228] 0 0
Edinburgh
Country [229] 0 0
United Kingdom
State/province [229] 0 0
Guildford
Country [230] 0 0
United Kingdom
State/province [230] 0 0
Leeds
Country [231] 0 0
United Kingdom
State/province [231] 0 0
London
Country [232] 0 0
United Kingdom
State/province [232] 0 0
Manchester
Country [233] 0 0
United Kingdom
State/province [233] 0 0
Northwood

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Daiichi Sankyo Company, Limited 3-5-1 Nihonbashihoncho, Chuo-ku, Tokyo
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available to whom?
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04494425